FDA issued a warning letter to Epitope Inc. last week for claimsthat the company has made about its OraSure HIV detectiondevice prior to approval.
Epitope of Beaverton, Ore., announced Sunday that FDA tookissue with four of the company's actions. First, it objected toclaims about OraSure's performance in materials presented at ascientific meeting in June. The agency prohibits promotionalclaims prior to drug approval.
The FDA also objected to alleged statements made by acompany representative at an October conference, a letterabout OraSure pricing that was sent to a potential customer anddistribution of OraSure devices to a clinical investigator prior tothe filing of a protocol amendment.
Epitope said FDA's letter is not expected to slow or alter FDAreview of the pre-market approval application for the oralspecimen collection device. On Friday, the company announcedthat FDA had begun pre-approval inspection of its Beavertonfacility and the facility of its contract manufacturer inTroutdale, Ore.
Epitope began marketing OraSure in 1991 to the insuranceindustry without FDA marketing approval. The companywithdrew the product at FDA's request in July 1991. -- BrendaSandburg
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